In reality there is always a degree of risk in all situations but risk reduction measures should minimise the probability and severity to an acceptable level of assurance. The degree of risk tolerated very much depends on the circumstances, the proximity to the patient and other controls that may follow the process being assessed before the product is used by the patient. It should be expected that risk mitigation plans are identified and implemented where any risk to patient safety is posed. Companies should take a holistic view and be mindful that critical issues often occur where multiple failures in systems occur together so risk reduction plans should be sufficiently robust to tackle such potential.
Inspectors will be assessing if risk assessments underate either the probability, severity or detection of occurrences in order to make it appear that there is minimal risk to the patient. The factual evidence behind statements may be challenged.
The impact should not consider the financial impact on a site/company to the detriment of the patient.
